FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Posts ICH Guidance on API GMPs

[ Price : $8.95]

FDA releases an International Conference on Harmonization guidance on Q7 Good Manufacturing Practice Guidance for Active Pharmaceu...

FDA Gives Breakthrough Status to AbbVie Hep C Therapy

[ Price : $8.95]

FDA grants AbbVie a breakthrough therapy designation for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibre...

FDA Clears NuVasives MAGEC Spinal Implant

[ Price : $8.95]

FDA clears a NuVasive 510(k) for its MAGEC system to be surgically implanted using its Reline posterior fixation system for treati...

Lehigh Valley Tech Seeks Action Against Virtus Pharma

[ Price : $8.95]

Lehigh Valley Technologies petitions FDA asking it to take enforcement action against Virtus Pharmaceuticals Holdings and to remov...

Evoked Photon Image Capture Device into Class 1

[ Price : $8.95]

Federal Register Final Order: FDA classifies the Evoked Photon Image Capture Device into Class 1 (general controls).

FDA Amends Animal Drug Regs for Approvals, Etc.

[ Price : $8.95]

Federal Register Final Rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug app...

FDA Warns on Homeopathic Teething Products

[ Price : $8.95]

FDA warns that homeopathic teething tablets and gels may pose a risk to infants and children.

Labeling Options for Medical Device Symbols

[ Price : $8.95]

Two CDRH officials say that a new final rule on using symbols in medical device labeling gives manufacturers more options.

Comments on Quality Metrics Technical Guidance

[ Price : $8.95]

Five stakeholders provide comments and suggestions to FDA on a draft guidance on quality metrics technical conformance.

Duke Center Sets Medical Device Priorities

[ Price : $8.95]

Duke Universitys National Evaluation System for health Technology says its new coordinating center is to implement a national syst...